Natural History and Post-Conversion Clinical Outcomes of the Fellow Eye in Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- PERCENTAGE OF fellow-eye myopia development in children with unilateral myopia receiving monocular MiSight® 1 Day treatment.
研究概览
简要总结
This investigator-initiated prospective observational cohort study aims to establish the first longitudinal clinical database evaluating fellow-eye myopia development in children receiving monocular MiSight® 1 Day treatment for unilateral myopia.
All myopic eyes will receive MiSight® 1 Day as standard clinical care, while the fellow eye will undergo regular observation without prophylactic intervention. If the fellow eye develops myopia (cycloplegic spherical equivalent ≤ -0.50 D), standard myopia control treatment, including MiSight® 1 Day or 0.05% atropine ophthalmic solution, will be initiated according to routine clinical practice and shared decision-making between the investigator and the child's parents The findings are expected to provide important evidence regarding fellow-eye refractive development, identify predictors of myopia conversion, optimize the timing of intervention, and support personalized myopia management in children with unilateral myopia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 7-18 years.
- •Cycloplegic SER ≤ -0.75 D in one eye and > -0.50 D in the fellow eye.
- •Cylinder ≤1.00 D in the myopic eye.
- •BCVA ≥20/25 (0.1 logMAR).
- •Willingness to wear MiSight® 1 Day for ≥10 hours/day and ≥6 days/week.
- •Willingness of the participant and parents to comply with the study procedures and complete 12 months of follow-up.
- •Written informed consent provided by the legal guardian.
排除标准
- •Previous orthokeratology treatment.
- •Previous atropine treatment exceeding one month.
- •Previous use of other myopia-control soft contact lenses.
- •Keratoconus, corneal degeneration, or other corneal disease.
- •Amblyopia, strabismus, or other significant binocular visual dysfunction.
- •Cataract, glaucoma, uveitis, retinal disease, or other significant ocular disease.
- •Systemic connective-tissue or neurological disease affecting vision.
- •Known allergy to atropine or contact lens materials.
- •Inability to comply with scheduled visits or anticipated relocation during the study period.
结局指标
主要结局
PERCENTAGE OF fellow-eye myopia development in children with unilateral myopia receiving monocular MiSight® 1 Day treatment.
时间窗: From enrollment to the end of treatment at 12 MONTHS
次要结局
未报告次要终点